The following data is part of a premarket notification filed by Welmed Inc. with the FDA for Welmed Hypodermic Syringe.
| Device ID | K070936 |
| 510k Number | K070936 |
| Device Name: | WELMED HYPODERMIC SYRINGE |
| Classification | Syringe, Piston |
| Applicant | WELMED INC. 15637 FOX COVE CIRCLE Moseley, VA 23120 |
| Contact | Darren Reeves |
| Correspondent | Darren Reeves WELMED INC. 15637 FOX COVE CIRCLE Moseley, VA 23120 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-03 |
| Decision Date | 2007-07-16 |
| Summary: | summary |